PARAVALVULAR LEAK OCCLUSION DEVICE FOR SELF-EXPANDING HEART VALVES

• US 20160256268A1
• Filed: 05/16/2016
• Published: 09/08/2016
• Est. Priority Date: 03/12/2013
• Status: Abandoned Application

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Dakin, Gregory James
• Application Number:
  US15/155,451
• Publication Number:
  US 20160256268A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2310/00011 Metals or alloys

Abstract

A system for replacing native valve function includes a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent. The system further includes an occluder device having an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section.

Claims

1. (canceled)

2. A system for replacing native valve function, the system comprising:

a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent; and

an occluder device comprising an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section.

3. The system of claim 2, wherein the stent includes an annulus section, a transition section, and an aortic section.

4. The system of claim 2, wherein the disk is expandable from a collapsed configuration to a relaxed configuration.

5. The system of claim 4, wherein the stent includes a plurality of cells, and the disk, in the relaxed configuration, has a size larger than a size of at least some of the cells of the stent and incapable of passing therethrough.

6. The system of claim 2, wherein the stent includes a plurality of struts and the fastener is coupled to at least one of the plurality of the struts.

7. The system of claim 2, wherein the body includes at least one of a metallic mesh or a shape-memory material.

8. The system of claim 2, wherein the body has an elliptical longitudinal cross-section.

9. The system of claim 2, wherein the body includes a metal mesh and polyester fiber intertwined with the metal mesh.

10. The system of claim 2, wherein the fastener includes a loop of wire.

11. The system of claim 2, wherein the disk is expandable and includes at least one of a metallic mesh or a shape-memory material.

12. The system of claim 2, further comprising:

a connector attached to the disk for coupling to a delivery device.

13. The system of claim 2, wherein the body includes multiple segments, each segment being capable of independent radial expansion from the other segments.

14. The system of claim 2, further comprising:

a delivery system including an outer sheath, an inner wire disposed within and translatable with respect to the outer sheath, and a connector attached to the inner wire, the connector being configured to couple the inner wire to the disk of the occluder device.

15. The system of claim 14, wherein the outer sheath is adapted to house the occluder device in a contracted configuration, and the outer sheath is sized to pass through a cell of the expandable stent.

16. A method for occluding a gap between a prosthetic heart valve and adjacent body tissue, the method comprising:

delivering an occluder to the heart valve, the occluder including (i) an expandable body, (ii) a fastener coupled to one end of the body, and (iii) an expandable disk coupled to another end of the body;

coupling the fastener to one end of the prosthetic heart valve; and

coupling the expandable disk to the prosthetic heart valve at a position spaced from the one end.

17. The method of claim 16, wherein the step of coupling the fastener includes positioning a loop around an apex of a cell at the one end of the prosthetic heart valve.

18. The method of claim 16, wherein the step of coupling the disk includes disposing the disk on an outside of at least one cell of the stent such that the disk cannot pass therethrough.

19. The method of claim 16, wherein delivering the occluder comprises disposing the occluder within a delivery system and advancing the delivery system to the heart valve.

20. The method of claim 19, further comprising:

coupling the expandable disk to an inner wire of the delivery system.

21. The method of claim 20, further comprising:

decoupling the expandable disk from the inner wire after coupling the expandable disk to the heart valve.